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"It’s hard for most people to grasp important eCTD concepts like lifecycle and granularity until they’ve seen them in action. The best way I’ve found to teach these concepts is by using an eCTD viewer... to educate authors, project teams, and Regulatory staff about granularity and document lifecycles. I’m not exaggerating when I say that getting a viewer in front of people is probably the best thing you can do to help your company successfully adopt the eCTD." (Source...)  

ROSETTA Phoenix™ eCTD Viewer is a feature-rich yet easy-to-use eCTD viewer for viewing regulated submissions prepared in Electronic Common Technical Document (eCTD) format.

It’s easy! You don’t need to learn a new language to use ROSETTA Phoenix. Designed for the sole purpose of viewing eCTD submissions, ROSETTA Phoenix is specifically for users who do not need to know the technical aspects of eCTD. ROSETTA Phoenix does not use any jargon or functionality restricted only to those who assemble, compile or publish eCTD submissions. Most users can start using and enjoying ROSETTA Phoenix eCTD viewer without any training. There is no doubt that eCTD publishing software is cumbersome for general users. This is why our customers choose ROSETTA Phoenix for viewing eCTD submissions, even though they may use another vendors’ eCTD publishing software.

It’s fast! It’s easy on the outside but fast on the inside! ROSETTA Phoenix’s smart eCTD loading and processing engine is among the fastest in the industry. Many companies select ROSETTA Phoenix eCTD viewer over other viewers because it outperforms other eCTD viewing/reviewing software in terms of the loading speed and the time it takes to construct the full lifecycle current and cumulative views. Furthermore, it does so without having to rely on any pre-built proprietary formats that need to be “refreshed” which is subject to human or process errors when there is a new eCTD submission. Four of the world’s largest pharmaceutical companies and other mid-size companies have chosen ROSETTA Phoenix Enterprise Edition as their global standard of viewing eCTD submissions primarily because of its fast loading capability.

It’s compliant! ROSETTA Phoenix is compliant with the latest eCTD specifications and is backwards-compatible with previous specifications from ICH and Canadian, E.U., Japanese, Swiss, Taiwanese, and U.S. regions. Any eCTD submissions, even those produced by other software vendor’s publishing tools, can be viewed through ROSETTA Phoenix, as long as they conform to ICH and regional eCTD specifications.

Compliance

Supports the latest international and regional eCTD specifications and is backwards-compatible with earlier specifications.

  • ICH eCTD specifications
  • Regional specifications: Health Canada, European Union/EMA, Japan/NIHS, Switzerland/SwissMedic, Taiwan/FDA and U.S./FDA, Saudi Arabia/GCC and South Africa/MCC
  • U.S. FDA Study Tagging File specifications

Easy Navigation and Viewing

  • Table of Contents View: Compliant with electronic Common Technical Document (eCTD) and regional section headings
  • Multi-tab design: Keeps multiple documents open and organized
  • Exposes all metadata for repeating sections, e.g. section 3.2.s
  • Filters for modules – see only the modules you want to see
  • Powerful and fast search on submission metadata and document titles
Lifecycle Operations
  • Intuitive visual indication for lifecycle operations and status
  • Easy access to lifecycle history
  • Open all "appended" documents in one click
  • Supports both implicit and explicit lifecycle operation models

Smart Loading and Fast Performance

  • Allows users to open a specific submission or the entire application
  • Builds the Table of Contents and the Current View on-the-fly
  • Smart caching, compression and refreshing techniques cut down loading time dramatically
Productivity Tools
  • Batch printing: Prints multiple documents with one click
  • My Briefcase: Downloads documents from server to your local hard drive for offline viewing
From individual Regulatory Affairs professionals to large life science companies, there are ROSETTA Phoenix eCTD Viewer solutions that can meet your needs and budget. Learn more...


Download ROSETTA Phoenix Desktop Edition Product White Paper (PDF) 
 

What's New in ROSETTA Phoenix R5.3:

Support for the latest regional eCTD specifications including the pilot testing of the Thailand eCTD M1 specifications v0.91 and South Africa (ZA) eCTD M1 specifications v2.1.
Bug fixes.

What's New in ROSETTA Phoenix R5.1:

Supports EU M1 spec v3.0 (DTD v3.0).
Supports Swiss M1 spec v1.3 (DTD v1.3).
Supports Thailand M1 spec v1.0 (Schema v1.0).
Supports GCC M1 spec v1.5 (DTD v1.1).
Supports Taiwan M1 DTD v2.
Adds a new option to open a PDF document with the default PDF reader in its own window (instead of the embedded PDF reader).
Adds a new user preference option to always open linked document with the default PDF reader in its own window.
Adds a new menu option to list all inter-document links in a PDF document. This function is accessible by right-clicking on the tab of an opened PDF document.
New embedded PFD reader powered by Foxit Software.
 
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